Trial Outcomes & Findings for Accuracy of Blood Loss Estimation After Vaginal Delivery (NCT NCT00462839)
NCT ID: NCT00462839
Last Updated: 2014-04-14
Results Overview
Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
1 hour
Results posted on
2014-04-14
Participant Flow
The study was conducted on two separate dates at Prentice Women's Hospital. Eight stations were set up in 8-12 hour periods in an empty labor and delivery room. Participants were randomized in blocks by provider type. The order of the volumes was randomized. Subjects were not informed that the volumes in the two groups were the same.
Participant milestones
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
|---|---|---|
|
Viewed First
STARTED
|
53
|
53
|
|
Viewed First
COMPLETED
|
53
|
53
|
|
Viewed First
NOT COMPLETED
|
0
|
0
|
|
Viewed Second
STARTED
|
53
|
53
|
|
Viewed Second
COMPLETED
|
53
|
53
|
|
Viewed Second
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accuracy of Blood Loss Estimation After Vaginal Delivery
Baseline characteristics by cohort
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
n=53 Participants
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
n=53 Participants
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: per protocal
Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.
Outcome measures
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
n=53 Participants
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
n=53 Participants
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
|---|---|---|
|
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
300 ml
|
-20.8 milliliters
Interval -56.8 to 15.1
|
-41.7 milliliters
Interval -77.7 to -5.7
|
|
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
500 ml
|
-53.5 milliliters
Interval -100.6 to -6.4
|
-96.0 milliliters
Interval -143.0 to -48.8
|
|
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
1000 ml
|
-32.8 milliliters
Interval -150.3 to 84.6
|
-145.3 milliliters
Interval -262.8 to -27.8
|
|
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
2000 ml
|
-178 milliliters
Interval -328.0 to -28.4
|
-829.8 milliliters
Interval -980.0 to -680.0
|
SECONDARY outcome
Timeframe: 1 hourPopulation: per protocol
Outcome measures
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
n=53 Participants
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
n=53 Participants
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
|---|---|---|
|
Number and Type of Care Providers Assigned to Study Arms.
Obstetrics
|
20 participants
|
22 participants
|
|
Number and Type of Care Providers Assigned to Study Arms.
Anesthesia
|
21 participants
|
22 participants
|
|
Number and Type of Care Providers Assigned to Study Arms.
Nursing
|
12 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 1 hourOutcome measures
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
n=53 Participants
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
n=53 Participants
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
|---|---|---|
|
Level of Training
Attending physician
|
19 participants
|
22 participants
|
|
Level of Training
Resident physician
|
22 participants
|
22 participants
|
|
Level of Training
Nurse
|
12 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 1 hourOutcome measures
| Measure |
Calibrated Vaginal Delivery Drapes Viewed First
n=53 Participants
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
Noncalibrated Drapes Viewed First
n=53 Participants
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
|
|---|---|---|
|
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
< 5 years
|
30 participants
|
29 participants
|
|
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
5-10 years
|
11 participants
|
13 participants
|
|
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
> 10 years
|
12 participants
|
11 participants
|
Adverse Events
Calibrated Vaginal Delivery Drapes Viewed First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Noncalibrated Drapes Viewed First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert J. McCarthy
Northwestern University Feinberg School of Medicine
Phone: (312)926-9015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place